SepsisICUPtO2OCTNCT01174966
Assessment of Transcutaneous Oxygen Tension/Oxygen Challenge Test in Intensive Care Unit (ICU) Patients
An observational study of Sepsis and Shock, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction of inspired oxygen (FiO2), called the "oxygen challenge test (OCT)", was associated with higher morbidity and mortality in human subjects. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects were sequentially admitted to the Department of Critical Care department of Peking Union Medical College Hospital from sept. of 2009 till the end of this study.
Who may be able to join
- 18 years of age or older
- Requiring a artery catheters, and pulmonary artery catheters or PiCCO-plus or central venous catheters
- FiO2<80% and SpO2>92%
- Consent informed
Who cannot join
- Not expected to live
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
dawei liu, MD, 010-65296091, dwliu98@yahoo.com
huaiwu he, 010-65296094, tjmuhhw@hotmail.com
About this study
Official title: Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients
The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction of inspired oxygen (FiO2), called the "oxygen challenge test (OCT)", was associated with higher morbidity and mortality in human subjects. Patients had negative O2 challenge test results, indicating that flow-dependent O2 consumption might have been present. Recent reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure of carbon dioxide probes have observed a relationship between low oxygen challenge test values to mortality and organ failure. The OCT values provides an accessible noninvasive method of detecting early shock.
To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI, DO2I、ScvO2.
Read more
This study explored:
- relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;
- relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2, ScvO2.
Read the detailed description
PtO2 index = PtO2/PaO2；tissue oxygen index=PtO2/FiO2；
5min OCT value = challenged 5minPtO2 - PtO2baseline；
10min OCT value= challenged 10minPtO2- PtO2baseline；
oxygen challenge index = （10minPtO2- PtO2baseline）/(10minPaO2-PaO2baseline)
- Keywords
- oxygen challenge test, shock, mortality, Oxygen Delivery Index, cardiac output index
- Medical subject headings
- Sepsis, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Survivor Nonsurvivor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU mortality
Measured: 28 day after enrollmented
Secondary outcomes (1)
hospital mortality
Measured: 28 day after enrollmented
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Investigators
- dawei liu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174966
- Sponsor's protocol ID
- PUMCH-ICU-LDW-OCT
- Acronym
- ICUPtO2OCT
- Status last verified
- Aug 2010
- First submitted
- 2 Aug 2010
- Last updated
- 4 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Yu M, Morita SY, Daniel SR, Chapital A, Waxman K, Severino R. Transcutaneous pressure of oxygen: a noninvasive and early detector of peripheral shock and outcome. Shock. 2006 Nov;26(5):450-6. doi: 10.1097/01.shk.0000228798.18174.6a.
PubMed 17047514Yu M, Chapital A, Ho HC, Wang J, Takanishi D Jr. A prospective randomized trial comparing oxygen delivery versus transcutaneous pressure of oxygen values as resuscitative goals. Shock. 2007 Jun;27(6):615-22. doi: 10.1097/shk.0b013e31802f0295.
PubMed 17505300Jonsson K, Jensen JA, Goodson WH 3rd, West JM, Hunt TK. Assessment of perfusion in postoperative patients using tissue oxygen measurements. Br J Surg. 1987 Apr;74(4):263-7. doi: 10.1002/bjs.1800740413.
PubMed 3580798Goeckenjan G, Strasser K. Relation of transcutaneous to arterial pO2 in hypoxaemia, normoxaemia and hyperoxaemia. Investigations in adults with normal circulation and in patients with circulatory insufficiency. Biotelemetry. 1977;4(2):77-87.
PubMed 610773Reed RL 2nd, Maier RV, Landicho D, Kenny MA, Carrico CJ. Correlation of hemodynamic variables with transcutaneous PO2 measurements in critically ill adult patients. J Trauma. 1985 Nov;25(11):1045-53.
PubMed 4057292
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transcutaneous Oxygen Tension and Oxygen Challenge Test in Adult Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01174966
- Acronym / sponsor ID
- ICUPtO2OCT / PUMCH-ICU-LDW-OCT
- Keywords
- oxygen challenge test, shock, mortality, Oxygen Delivery Index, cardiac output index
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 4 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The lack of subcutaneous partial pressure of oxygen (PO2) rise in response to high fraction of inspired oxygen (FiO2), called the "oxygen challenge test (OCT)", was associated with higher morbidity and mortality in human subjects. Patients had negative O2 challenge test results, indicating that flow-dependent O2 consumption might have been present. Recent reports using the noninvasive transcutaneous PO2 (PtO2) and transcutaneous partial pressure of carbon dioxide probes have observed a relationship between low oxygen challenge test values to mortality and organ failure. The OCT values provides an accessible noninvasive method of detecting early shock.
To date,these studies of OCT in the ICU patients are rarely. No one has quantified OCT to CI, DO2I、ScvO2.
This study explored:
- relationship between patient factors, hemodynamic variables, PtO2, and OCT to mortality;
- relationship between PtO2 index, tissue oxygen index, oxygen Challenge index to CI, DO2, ScvO2.
Detailed description
PtO2 index = PtO2/PaO2；tissue oxygen index=PtO2/FiO2；
5min OCT value = challenged 5minPtO2 - PtO2baseline；
10min OCT value= challenged 10minPtO2- PtO2baseline；
oxygen challenge index = （10minPtO2- PtO2baseline）/(10minPaO2-PaO2baseline)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivor Nonsurvivor | – | – |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects were sequentially admitted to the Department of Critical Care department of Peking Union Medical College Hospital from sept. of 2009 till the end of this study.
Key inclusion criteria (4 listed)
- 18 years of age or older
- Requiring a artery catheters, and pulmonary artery catheters or PiCCO-plus or central venous catheters
- FiO2<80% and SpO2>92%
- Consent informed
Key exclusion criteria (1 listed)
- Not expected to live
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ICU mortality
Time frame: 28 day after enrollmented
1 secondary outcome
hospital mortality
Time frame: 28 day after enrollmented
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2010.
- Background: PubMed 17047514Yu M, Morita SY, Daniel SR, Chapital A, Waxman K, Severino R. Transcutaneous pressure of oxygen: a noninvasive and early detector of peripheral shock and outcome. Shock. 2006 Nov;26(5):450-6. doi: 10.1097/01.shk.0000228798.18174.6a.
- Background: PubMed 17505300Yu M, Chapital A, Ho HC, Wang J, Takanishi D Jr. A prospective randomized trial comparing oxygen delivery versus transcutaneous pressure of oxygen values as resuscitative goals. Shock. 2007 Jun;27(6):615-22. doi: 10.1097/shk.0b013e31802f0295.
- Background: PubMed 3580798Jonsson K, Jensen JA, Goodson WH 3rd, West JM, Hunt TK. Assessment of perfusion in postoperative patients using tissue oxygen measurements. Br J Surg. 1987 Apr;74(4):263-7. doi: 10.1002/bjs.1800740413.
- Background: PubMed 610773Goeckenjan G, Strasser K. Relation of transcutaneous to arterial pO2 in hypoxaemia, normoxaemia and hyperoxaemia. Investigations in adults with normal circulation and in patients with circulatory insufficiency. Biotelemetry. 1977;4(2):77-87.
- Background: PubMed 4057292Reed RL 2nd, Maier RV, Landicho D, Kenny MA, Carrico CJ. Correlation of hemodynamic variables with transcutaneous PO2 measurements in critically ill adult patients. J Trauma. 1985 Nov;25(11):1045-53.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dawei liu, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Shock, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dawei liu, MD (010-65296091, dwliu98@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU mortality (time frame: 28 day after enrollmented). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01174966, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2010.